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The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording and stimulation only. The LASSO 2515 Variable Circular Mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

The LASSO 2515 Variable mapping catheter when used in conjunction with electrophysiological pacing and recording equipment is designed to acquire, analyze and display electrical activity in the human heart. In particular the device is targeted for use in the atrial chambers of the heart and is particularly well-suited for placement in or near the pulmonary veins in the left atrium. The catheter transmits electrical pulses from the pacing equipment and intracardiac electrical signals to the recording equipment for display as electrograms (ECG traces). Trained physicians interpret the electrograms in diagnosing cardiac arrhythmias.

The Variable LASSO™ 2515 electrophysiologic mapping catheter now incorporates a tip with a variable radius mechanism that allows selection of radii in a range from 15-25 mm. The LASSO predicate device cleared in K002333 is marketed with fixed radii of 10, 15, 20 and 25 mm. The subject device will allow the user to select a continuum of radii from 10- 25 mm. To facilitate user selection of this range of radii, design changes were required in the handle of the catheter. The Variable Lasso handle mechanism now has two independently operating deflecting mechanisms that control tip deflection and circular spine expansion and contraction. Tip deflection is controlled with a thumbknob attached to the distal end of a piston mechanism enclosed in the handle barrel. The spine contraction and expansion mechanism is also controlled by the movement of a puller wire attached to a cam assembly mechanism in the catheter handle that when rotated either contracts or expands the distal loop in a diameter range from 15 to 25 mm.

The provided 510(k) summary for the LASSO™ 2515 Variable Circular Mapping Catheter describes the device's design, intended use, and comparison to a predicate device, but it does not contain details of a clinical study or specific acceptance criteria with quantifiable performance metrics.

The document states:

• "Various non - clinical bench tests were conducted to verify conformance of Variable Lasso catheter to design and performance specifications. Mechanical, dimensional, and reliability tests were performed and all requirements were met prior to submission of the 510k. No new questions of safety and effectiveness were raised as a result of these tests."

This indicates that the device's acceptance was based on bench testing ensuring it met design and performance specifications, likely related to its mechanical function, dimensions, and reliability. The 510(k) pathway for this device relies on substantial equivalence to a predicate, not on new clinical efficacy studies establishing performance against specific acceptance criteria in patient populations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as a formal clinical study with such elements was not conducted or reported in this summary.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated in quantitative terms within this document. The general criteria appear to be "conformance... to design and performance specifications" and "all requirements were met." These requirements would likely relate to mechanical properties (e.g., deflection range, circular spine expansion/contraction, durability).
   • Reported Device Performance: The document states that "all requirements were met" for mechanical, dimensional, and reliability tests. No specific performance values (e.g., precision of radius selection, force required for deflection, number of cycles tested for durability) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not applicable as no human-subject clinical test set is described. Bench tests would have involved a sample size of catheters, but this detail is not provided.
   • Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable as no human-subject clinical test set is described where expert ground truth would be established. For bench testing, "ground truth" would be engineering specifications and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable; this is a medical device for mapping cardiac electrical activity, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not applicable; this is a physical medical device, not an algorithm. Bench testing assesses the device's physical performance, which is "standalone" in that it's testing the device itself, but it's not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the bench tests, the "ground truth" would have been the engineering design specifications and objective physical measurements (e.g., measuring the exact radius achieved, forces, deflections) using standard metrology and testing equipment.

8. The sample size for the training set

   • Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

   • Not applicable.

In summary, the 510(k) relies on bench testing and a comparison to a predicate device for substantial equivalence, rather than a clinical study with specific performance acceptance criteria for patient outcomes or diagnostic accuracy. The "acceptance criteria" were implied to be the successful meeting of the device's design and performance specifications during in-house mechanical, dimensional, and reliability testing.

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